Business Imperatives

  • A US-based multinational company expressed eCTD submission compliance concerns in the EAEU region.
  • Consultation support was needed for filing submissions for existing and new applications within the EAEU region.
  • Transition support from the old (paper) to the new (XML) submission format as per HA requirements was also requested.

Objectives

The objective was to provide consultation support for filing submissions for both existing and new applications within the EAEU region, specifically in Russia. Additionally, transition support was provided from the old (paper) to the new (XML) submission format, aligning with the requirements of the Health Authorities.

Problem Statement

  • There was dissatisfaction with the support provided by the existing vendor.
  • eCTD submissions in EAEU were noted to be unclear and complex.
  • A lack of local Regulatory expertise and association with the HA therein was identified.
  • Longer approval times were experienced.
  • Evaluation of large volumes of documents was conducted.

Freyr Solutions and Services

Freyr Solutions and Services
  • Consultation support was provided for filing submissions for both existing and new applications within the EAEU region.
  • Transition support from the old (paper) to the new (XML) submission format was facilitated with Freyr's assistance.
  • Freyr aided in the transition of 8+ products, execution of 15+ submissions, and processing of 5+ new submissions.
  • Recognized the absence of local Regulatory expertise and connections with Health Authorities (HA).
  • Evaluated the difficulty of processing large document volumes for submission.
  • Implemented a strategy to overcome these challenges by offshore submission of prescription medicines to the local HA, maintaining quality and achieving rapid turnaround times.
  • Deployed publishing and support services for XML guideline changes, streamlining submission processes.
  • Successfully tackled the complexities of EAEU-specific regulations, ensuring compliance.
  • Accelerated interactions with Health Authorities (HA), expediting approval processes.
  • Achieved 100% quality with zero errors and rapid turnaround times (TAT).

Freyr’s meticulous approach and project management resulted in the successful submission of the MAA within the stipulated timeline. The client experienced swift approvals, enabling them to advance their product in the competitive pharmaceutical and biologics market.